Post-Market Surveillance Lead, Regulatory Reporting

LeMaitre; Burlington (MA); Vor Ort; USD 120.000 - 140.000; Vollzeit

Zusammenfassung

LeMaitre Vascular seeks a quality professional to oversee complaint handling and regulatory reporting submissions. You will manage investigations, interact with regulators, and support quality metrics and remediation activities through to closure.

The role requires a Bachelor's in a relevant field and several years of medical device experience, including post-market reporting and CAPA/validation work. This hybrid-remote friendly posting describes a critical compliance function.

Qualifikationen

• Bachelor's degree in Engineering, Microbiology, Biology, Biomedical Engineering, or equivalent field required.
• 2 years’ experience in Medical Devices or related industry.
• 3 years’ experience managing complaints.
• 1 year experience independent post market regulatory reporting (MDR and/or Vigilance), drafting and submissions.
• Competency in at least two of the following areas: CAPAs, NCMRs, Validations, Audit, Design Control, Complaints, or Product Testing.

Aufgaben

• Processes complaints and regulatory reports to ensure documentation, review, investigation, and formal closure.
• Interfaces with internal/external customers and regulatory agencies as required.
• Prepares and contributes responses to regulatory inquiries as needed.
• Supports quality metrics development and monitoring, participating in reviews.
• Reviews complaint data and prepares reports for internal customers.
• Provides support for other Quality functions, including field actions and corrective actions.
• Adheres to company policies and documentation requirements.
• T recomends respectful conduct and professional behavior.
• Other duties as assigned.

Kenntnisse

CAPAs

NCMRs

Validations

Audit

Design Control

Complaints

Product Testing

Ausbildung

Bachelor's degree in Engineering, Microbiology, Biology, Biomedical Engineering, or equivalent

Tools

Microsoft Office

Jobbeschreibung

LeMaitre Vascular seeks a quality professional to oversee complaint handling and regulatory reporting submissions. You will manage investigations, interact with regulators, and support quality metrics and remediation activities through to closure.

The role requires a Bachelor's in a relevant field and several years of medical device experience, including post-market reporting and CAPA/validation work. This hybrid-remote friendly posting describes a critical compliance function.